Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-08-31

Brief Summary

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The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).

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Detailed Description

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Conditions

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Ambulatory Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Complete Smart Angel

Smat Angel application with artificial intelligence

Group Type EXPERIMENTAL

Smart Angel

Intervention Type OTHER

Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms

Basic Smart Angel

Smat Angel application without artificial intelligence

Group Type EXPERIMENTAL

Smart Angel

Intervention Type OTHER

Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smart Angel

Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is undergoing ambulatory surgery for:

* in orthopedics: shoulder (arthroscopy, abutment, prosthesis), hip (prosthesis, arthrolysis), knee (osteotomy, ligamentoplasty), ankle (prosthesis, ligamentoplasty) foot (hallux valgus); removal of major or multi-site equipment;
* digestive (cholecystectomy, hernia repair, partial gastrectomy, colectomy, cleaning);
* in gynecology (hysterectomy, oophorectomy, mastectomy, quadrantectomy, dissection, cystoplasty, sphincter);
* in urology (total or partial resection of the prostate);
* ENT (thyroidectomy, tonsillectomy);
* Neurosurgery (herniated disc);
* Vascular (stripping varix, creating fistula).
* The patient has sufficient intellectual and cognitive capacity to use the devices
* The patient must pass the test performed during the anesthesia consultation, namely:

* open and connect the tablet,
* activate the measurement of the blood pressure and the measurement of the oxygen saturation,
* be connected to a 4G network

Exclusion Criteria

* The subject is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant
* The patient is undergoing emergency or minor surgery
* Patient has a psychological class ASA 5
* Patient is non-eligible for ambulatory surgery for medical reasons (decompensated medical pathology) or social reasons according to the criteria defined by the société française anesthésie réanimation. Person lives alone or has a geographical distance from a hospital center\> 30 km (or\> 45 min by car).
* Patient who doesn't classify for ambulatory surgery at time of discharge

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christhophe Boisson

Role: STUDY_DIRECTOR

CHU Nimes

Locations

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